Prospective Validation of Clini-biological Parameters Including Initial Hemostasis, Which Improve the Prediction of Death at 1 Month Among Patients With Septic Shock

Completed

• Conditions: Shock, Septic
• Interventions: Biological: Routine biological analyses

• Registration Number: NCT01231672
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

A prognostic score was proposed by the investigative team to predict death at 1 month. This score is based on certain biological markers, scored under emergency conditions in the first 24 hours of routine clinical practice management for septic shock.

The main objective of this multicenter study is to validate the performance of the score in terms of area under the ROC curve and negative predictive value.

Detailed Description

There are two secondary objectives:

* Validate a prognostic score for death at the end of the first week from initial data.

* Validate a predictive score of disseminated intravascular coagulation (DIC) in patients with septic shock by comparing with the Gold Standard of the International Society on Thrombosis and Haemostasis (overt-DIC in the first 5 days after inclusion).

As for the main objective, these scores are based on biological markers scored under emergency situations within the first 24 hours of routine clinical practice management for septic shock.

The objectives and endpoints stated correspond to the protocol directly submitted to ethics authorities prior to the first inclusion and can be verified by contacting the Committee for the Protection of Persons Sud Mediterranée III (mail: CPP SUD-MEDITERRANEE III, UFR MEDECINE 186, chemin du Carreau de Lanes CS 83021, 30908 NIMES Cedex 2 FRANCE. Study reference: 2008.11.04 bis) For more information: carey.suehs@chu-nimes.fr

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2010-10-29
• Study First Submitted QC: 2010-10-29
• Study First Posted: 2010-11-01
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-26
• Last Update Posted: 2015-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 780

Inclusion Criteria

• patient (or representative) received the information notice
• patient has hemodynamic insufficiency of non-traumatic or cardiogenic origin associated with severe sepsis (treated with Noradrenalin) and organ dysfunction, hypoperfusion or hypotension
• body temperature > 38.3°C or < 36°C
• heart rate > 90 bpm
• Tachypnea > 20 C/min or PaCO2 < 32 mmHg or mechanical ventilation
• leukocytes > 12000 µL-1 ou < 4000 µL-1 ou > 10% immature forms
• oliguria < 0.5 ml/kg/h for at least 2 hours
• abrupt alteration (24 h) of conscienceness
• thrombocytopenia < 100 000 G/L or disseminated intravascular coagulation
• mottled skin and / or capillary refill time> 3 sec
• PaO2/FiO2 < 300 mmHg ou < 40KPas
• Lactatemia > 2mMol/l
• septic shock: Systolic Blood Pressure (SBP) > 90 mmHg or need for vasopressors to maintain SBP> 90 mmHg despite a prior filling (20-30 ml / kg of macromolecules or 40 to 60 ml / kg of normal saline (or decrease in SBP> 40% in the hypertensive)

Exclusion Criteria

• patient is dying or limitation or cessation of active treatment
• patient is already included in another trial
• patient or family refusal
• patient not affiliated with a social security system

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Septic shock patients	Routine biological analyses	-

Primary Outcome Measures

Name	Time	Method
Negative predictive value of the studied prognostic score	24 hours (studied score parameters); 1 month (mortality)	The biological parameters measured at the time of admission to the intensive care unit and that make up the prognostic score for death at 1 month will be collected. The event "death within 1 month" will be analyzed. For patients discharged from service before the end of the first month, the clinician will still be informed concerning possible death.; The studied biological parameters correspond to routine coagulation and hematological parameters for patients in septic shock, according to SFAR (Société Française d'Anesthésie et de Réanimation) recommendations and the SRLF (Société de Réanimation de Langue Française) Consensus (2002).
AUC of the studied prognostic score	24 hours (studied score parameters); 1 month (mortality)	The biological parameters measured at the time of admission to the intensive care unit and that make up the prognostic score for death at 1 month will be collected. The event "death within 1 month" will be analyzed. For patients discharged from service before the end of the first month, the clinician will still be informed concerning possible death.; The studied biological parameters correspond to routine coagulation and hematological parameters for patients in septic shock, according to SFAR (Société Française d'Anesthésie et de Réanimation) recommendations and the SRLF (Société de Réanimation de Langue Française) Consensus (2002).

Secondary Outcome Measures

Name	Time	Method
Negative predictive value for the studied prognostic score	24 hours (studied score parameters); 5 days (DIC)	Our secondary objective is to validate a clinicobiological score, including hemostasis parameters (clotting factors and coagulation activation) and a clinical score (SOFA) for predicting the occurrence of DIC in the first 5 days after inclusion.; The DIC score will be calculated according to ISTH (International Society on Thrombosis and Haemostasis) recommandations (Taylor et al, 2001).
AUC of the studied prognostic score	24 hours (studied score parameters); 5 days (DIC)	Our secondary objective is to validate a clinicobiological score, including hemostasis parameters (clotting factors and coagulation activation) and a clinical score (SOFA) for predicting the occurrence of DIC in the first 5 days after inclusion.; The DIC score will be calculated according to ISTH (International Society on Thrombosis and Haemostasis) recommandations (Taylor et al, 2001).
Negative predictive value of the studied prognostic score	24 hours (studied score parameters); 1 week (mortality)	Biological parameters at the time of intensive care unit admission and making up the prognostic score for death at 1 week will be collected. The event "death within 1 week" will be analyzed. For patients discharged from the department before the end of the first week, the clinician will still be informed of possible death. For the prognostic score at 1 week, a single biological parameter is used: fibrinogen. Age and SAPSII are also included in the score.

Trial Locations

Locations (7)

CHU de Clermont Ferrand - Hôpital Estaing; 🇫🇷 Clermont Ferrand, France

Centre Hospitalier Universitaire de Montpellier; 🇫🇷 Montpellier, France

CHU de Saint Etienne; 🇫🇷 Saint Etienne cedex 2, France

Centre Hospitalier Universitaire de Nîmes; 🇫🇷 Nîmes, France

APHM - Hôpital de la Conception; 🇫🇷 Marseille, France

CHU de Nice; 🇫🇷 Nice, France

AP-HM Hôpital Nord; 🇫🇷 Marseille, France